Quality Systems Manager II in Cambridge, MA at Integrated Resources, Inc

Date Posted: 12/24/2019

Job Snapshot

Job Description

Position Title: Internal Supplier & Audit Lead
Reporting To:Head of Internal & Supplier Audit
Function (Corp, SP, HGT, RM): Research and Development
Department: Quality Assurance & Compliance
Job Level: Manager

Primary Duties
Key areas of accountability and budget responsibility, if applicable.
Under the direction of the Head of Internal & Supplier Audits, this position is responsible for supporting the overall execution of the overall Internal Suppler & Audit (ISA) strategy and ensure adherence to R&D QA & Compliance (QA&C) Operational objectives.
Primary responsibilities of this position are to:
Provide coordination and support in execution of overall ISA strategy and R&D QA&C Operational objectives
Manage and oversee external auditors
Administrator and/or User for ISA Systems: Supplier Database and SharePoint
Provide support for QA & Compliance Regulatory Agency Inspections
Provide professional expertise and leadership in applicable guidance and regulations, proactively identifying potential areas of non-compliance and risk R&D Business Partners and Client.

Responsibilities

20-50% of Time Audit Coordination
- Liaise and network with internal and external business partners to implement ISA strategy
- Lead or Co-Lead the planning, execution and close out, of assigned ISA audits
- Auditor and/or co-auditor assigned ISA audits
- Manage ISA driven CAPAs, effectiveness checks, and issue escalation
- Support management of ISA database as needed
- Lead or support ISA facilitated meetings.
- Participate in QA&C project initiatives (System Development and COE driven)

20-40% of Time - External Auditor Oversight
- Oversee and direct relationships with external auditor partners
- Collaborate with COE partners to identify potential deficiencies or issues for escalation to ISA management and manage escalation
- Review, approve and manage external auditor partners MSA and Scope of Work and associated ISA audit work product
- Review and approve external auditor partner ISA audit work product
- Provide support and assistance for assignment and management of external auditors within QA&C, as needed

5-20 % of Time - ISA Supplier Database & SharePoint Management
- Provide back-up support to ISA Associate
- Assist and/or provide training on ISA database as necessary
- Assist and/or provide training on ISA SharePoint as necessary
- Serve as designated ISA database super-user
- Serve as designated ISA SharePoint super-user

5-15% of Time - Regulatory Agency Support
- Support, as needed, the preparation, conduct follow-up/responding, and lessons learned to GXP inspections

Education and Experience Requirements
Bachelor's degree in a life science or equivalent experience; Graduate degree in a scientific discipline or program management a plus
Minimum of 5 years' of pharmaceutical experience, global exposure preferred
Ideal candidate will have broad experience in product development, regulatory compliance, supplier management, database and system administration, and GxP auditing.

Key Skills, Abilities, and Competencies
Strong knowledge and/or awareness of local and international regulations. Maintains awareness of newly published regulations.
Proficient knowledge of MS Word, Excel, Access, PowerPoint & Outlook; working knowledge of Trackwise a plus.
Collaborative team player who has the ability to think and act quickly and identify creative solutions
Project management skills with a focus on attention to detial
Leadership skills, and ability to inspire colleagues
Excellent communication and interpersonal skills.
A self-starter, who motivates, has tact and diplomacy and is able to define and prioritize tasks within a project
Ability to foster and balance a culture of compliance within a culture of innovation
Ability to influence without authority, in a matrix environment
Understanding of the: drug development processes, clinical development operations, vendor outsourcing and procurement processes, regulatory affairs, GXP and internal process auditing

Complexity and Problem Solving
Works on diverse scope of problems requiring analysis of situation or data evaluation of identifiable factors.
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Receives assignments in the form of objectives and establishes goals to meet objectives.

Internal and External Contacts
Reports directly to Head of Internal & Supplier Audits
Interacts across R&D QA & Compliance and R&D Business Partners

Other Job Requirements
Domestic and international travel may be required per business need.
Must have a global mindset.